Quality & Certification
Certified Quality — Measurable and Documented.
Quality at laserKRAFTwerk is not a promise — it is measurable, documented, and verifiable at any time.
laserKRAFTwerk GmbH operates under a quality management system certified to both DIN EN ISO 9001:2015 and DIN EN ISO 13485:2021. Both certifications are maintained simultaneously, with regular surveillance audits and periodic re-certification by an accredited certification body.
Quality Management System
DIN EN ISO 9001:2015
Certified quality management for industrial manufacturing. Validated processes, documented controls, continuous improvement.
QMS Medical Devices
DIN EN ISO 13485:2021
The internationally recognised standard for medical device manufacturers and suppliers. Mandatory for UDI-compliant marking.
Quality Controls — Standard on Every Order
- ✓Validated and documented processes for every material and marking type
- ✓Process parameters traceable to each production batch
- ✓15-year document archiving as standard — not an option
- ✓Automatic code quality inspection per ISO/IEC 16022 for every DataMatrix code produced
- ✓100% visual inspection of every component
- ✓Measurement reports and batch records available on request
ISO 13485 — What It Means for You
ISO 13485 is the international quality management standard for organisations in the medical device supply chain. Our certification enables medical device manufacturers to qualify us as a supplier without additional on-site audit effort. Our defect rate since 2017 is below 0.01% — 400 defects across more than 4 million parts processed.
MDR Compliance & UDI Marking
Our UDI marking process is aligned with EU Medical Device Regulation MDR 2017/745. We mark DataMatrix codes and human-readable lines compliant with the UDI placement and content requirements. All production data is archived for 15 years, with full process traceability per component.
Certificate Download
Current, valid certificates as PDF — ready to download for your supplier file.